Measuring Force During Subpial Resection Procedure Using a Novel Ex Vivo Calf Brain Model With Integrated Sensor
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- McGill University
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Forces applied to the brain during each simulated subpial resection procedure step
Study Overview
Brief Summary
Neurosurgery is a high-stakes surgical specialty where errors can result in significant morbidity. The amount of force applied simultaneously on the brain with multiple different instruments during complex neurosurgical procedures is a critical safety metric that, to the investigators' knowledge, has not been previously measured in a realistic operative environment.
The investigators have therefore developed a simulation platform integrating an ex vivo calf brain and a 3D-printed skull model attached to a force sensor capable of capturing real-time forces applied to the brain. A case series study will be conducted to evaluate the pattern of force applied. Medical students, neurosurgical residents, and staff neurosurgeons from McGill University will be recruited to perform subpial resections using our ex vivo calf brain simulation platform. The forces applied by the microscissors, bipolar forceps, and ultrasonic aspirator onto the brain will be captured. This study aims to demonstrate the spectrum of force applied during a neurosurgical procedure using an ex vivo calf brain model.
Detailed Description
Background and Rationale: The subpial resection technique is a complex neurosurgical procedure that is essential for brain tumor and epilepsy surgery. However, opportunities for trainees to gain hands-on experience with this procedure without risk to patient safety are limited. The force applied on the brain during tool-tissue contact is a critical factor impacting patient safety. While virtual simulation platforms enable force monitoring, ex vivo animal brains cannot readily capture quantitative data. The investigators have therefore developed a prototype of a simulation platform that integrates a force sensor and a calf brain and can accurately detect real-time forces during simulated subpial resections. This study seeks to gauge the force spectrum using this ex vivo calf brain force detection system.
Hypothesis: The simulation platform will accurately measure forces applied by novice, intermediate, and expert participants with surgical instruments on an ex vivo calf brain during simulated subpial resection procedures.
Co-Primary Outcomes: To assess the individual and combined instrumental force applications during subpial resection procedures in an ex vivo calf brain model.
Secondary Outcome: To differentiate levels of expertise of trial participants.
Setting: Montreal Neurological Institute and Hospital, McGill University, Montreal, Quebec, Canada.
Study Design
- Study Type
- Observational
- Observational Model
- Case-only
- Time Perspective
- Cross-sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Right-handed medical students, neurosurgical residents, and staff neurosurgeons from McGill University
Exclusion Criteria
- Left-handed individuals
Outcomes
Primary Outcomes
Forces applied to the brain during each simulated subpial resection procedure step
Time Frame: 1 day of study
Throughout each simulated ex vivo subpial resection procedure, forces applied to the brain during tool-tissue contact will be measured by the force/torque sensor in grams and Newtons.
Secondary Outcomes
No secondary outcomes reported
Investigators
Rolando Del Maestro
Director, Neurosurgical Simulation and Artificial Intelligence Learning Centre
McGill University
Study Sites (1)
Identifiers
- NCT ID
- NCT07650253
- Other Study IDs
- 2018 4395, Trial 1
Dates
- First Submitted
- (3 months ago)
- First Posted
- (3 months ago)
- Primary Completion
- (2 months ago)
- Study Completion
- (2 months ago)
- Last Verified
- (2 months ago)
- Last updated
- (last month)
Regulatory & Sharing
- FDA Regulated Drug
- No
- FDA Regulated Device
- No
- IPD Sharing Plan
- Yes
- Has Results
- No